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Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen.

NCT06402591 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 751

Last updated 2024-05-07

No results posted yet for this study

Summary

The goal of this randomized control trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. The main question\[s\] it aims to answer are:

* Is an extended regimen compared to a single dose of cefazolin associated with an increased infection-free implant survival within one year after index revision arthroplasty of the hip or knee?
* What are the incidence, risk factors, treatment outcome and prognosis of surgical site infections and periprosthetic joint infection during follow-up?
* What is the safety and tolerance of the antimicrobial prophylaxis regimens used?
* What are the antimicrobial susceptibility patterns of micro-organisms causing PJI during follow-up?
* What is the patient' physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty, using patient related outcome measurements (PROMS)?

\[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].

Conditions

  • Infection Prosthesis Hip and Knee
  • Infection, Prosthesis Related
  • Joint Infection
  • Infection, Surgical Site
  • Surgical Site Infection
  • Infection Pro

Interventions

DRUG

Cefazolin

cefazolin extended prophylaxis 5 days (15 doses)

Sponsors & Collaborators

  • Sint Maartenskliniek

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Bart-Jan Kullberg, prof. Dr · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-12-01
Completion
2024-12-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402591 on ClinicalTrials.gov